28 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Rotium
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
FDA UDI
FX SOLUTIONS·03701037309285·HAND REAMER Ø10mm
K-SPONGE-II CHAYET LASIK DRAIN
FDA UDI
KATENA PRODUCTS, INC.·00841668112205·
Implant, Dermal, For Aesthetic Use
FDA Pre-Market Approval
FDA Class 3
·saypha® ChiQ
SPACELABS HEALTHCARE
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522122705·10 LD PNT CBL PINCH CC/VOYAGER
Spacelabs Healthcare
FDA UDI
SPACELABS HEALTHCARE (WASHINGTON), INC·10841522126079·10 LD PNT CBL PINCH CC/VOYAGER
XM Shaft Single End Trial
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215066239·
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250021400·ceraMotion® Zr Base Dentin A1, 40 g / dental ce...
devemed
FDA UDI
devemed GmbH·04061644030477·Membrane lift | Granulat plugger "Mazor" # 6
5....
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011250021200·ceraMotion® Zr Base Dentin A1, 20 g / dental ce...
HEMODIALYSIS BLOODLINES
FDA Adverse Event
Malfunction
·B. BRAUN MEDICAL INC.·Product code FJK·October 22, 2025
VALKYRIE® - POWER DRIVER
FDA Adverse Event
Malfunction
·JEIL MEDICAL CORPORATION·Product code KIJ·January 22, 2026
Z5m(t)
FDA 510(k)
FDA Class 2
·Dental
VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Apex Lifts
FDA UDI
JOERNS HEALTHCARE, LLC·00810055881086·C-HLA-2 W/MESH LG U-SLING W/O HD SUPPORT
Reicodent
FDA UDI
devemed GmbH·04061644037223·Membrane lift | Granulat plugger "Mazor" # 6
5....
VALKYRIE® - POWER DRIVER
FDA Adverse Event
Malfunction
·JEIL MEDICAL CORPORATION·Product code KIJ·January 29, 2026
ONYX
FDA Adverse Event
Injury
·COVIDIEN (IRVINE)·Product code MFE·April 24, 2017
ACCU-CHEK TENDER INFUSION SET
FDA Adverse Event
Malfunction
·DISETRONIC MEDICAL SYSTEMS·Product code FPA·November 14, 2008
PREMIUM SURGICLIP M-11.5 TITANIUM
FDA Adverse Event
Injury
·USSC PUERTO RICO·Product code GDW·September 9, 2011